(Reuters) - The U.S. Food and Drug Administration approved
Tesaro Inc's oral drug rolapitant (Varubi) for treatment for
chemotherapy-induced nausea and vomiting in adults, the company
said on Wednesday.

Chemotherapy-induced nausea and vomiting, considered one of
the most acute side effects of cancer therapy, occurs in up to
80% of patients, according to the National Institutes of Health.

Rolapitant was approved for use in combination with other
antiemetic agents in adults for the prevention of delayed nausea
and vomiting associated with initial and repeat courses of
emetogenic cancer chemotherapy, including, but not limited to,
highly emetogenic chemotherapy, the company said.

Rolapitant works by blocking the activation of neurokinin
(NK)-1 receptors in the nervous system, which play a role in
nausea and vomiting.

The approval was based on four trials of patinets receiving
emetogenic chemotherapy, including cisplatin, carboplatin and
anthracycline/cyclophosphamide-based regimens, the company said.

Rolapitant is Tesaro's first product to win FDA approval. It
is expected to go on sale in the fourth quarter and will address
a $1 billion market in the United States, the company said.